UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043060 |
|---|---|
| Receipt number | R000049160 |
| Scientific Title | Examination of the absorption of neoxanthin into the body |
| Date of disclosure of the study information | 2021/01/25 |
| Last modified on | 2021/01/20 10:48:16 |
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Basic information
Public title
Examination of the absorption of neoxanthin into the body
Acronym
Examination of the absorption of neoxanthin into the body
Scientific Title
Examination of the absorption of neoxanthin into the body
Scientific Title:Acronym
Examination of the absorption of neoxanthin into the body
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm whether neoxanthin is absorbed into the body by 28 days continuous intake of baby leaves.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum neoxanthin levels before and after intake of baby leaves for 14 and 28 days.
Key secondary outcomes
Serum levels of beta-carotene and lutein before and after intake of baby leaves for 14 and 28 days.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Baby leaf intake
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Employees of KAGOME Co. Ltd.
2.Who ages more than 20 years old.
3.Who can make self-judgment, voluntarily agreed to participate to this study, and provide written informed consent.
Key exclusion criteria
1.Who have or have a history of serious diseases such as gastrointestinal, diabetes, cardiovascular disease, liver disease, renal disease, or heart disease.
2.Who are pregnant or breast-feeding or willing to be pregnant during this study.
3.Who have allergic to test food.
4.Who have irregular lifestyles (diet, sleep, exercise)
5.Who have a smoking habit
6.Who are taking supplements containing calcium
7.Who have had stones in the past or have been told by a doctor that there is a risk of stones
8.Who have participated in other clinical studies during this study, or willing to be that.
9.Who are judged unsuitable for this study by principal investigator.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Shigenori |
| Middle name | |
| Last name | Suzuki |
Organization
Kagome Co., Ltd.
Division name
Nature & Wellness Research Department
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan
TEL
0287-36-2935
Shigenori_Suzuki@kagome.co.jp
Public contact
Name of contact person
| 1st name | Shigenori |
| Middle name | |
| Last name | Suzuki |
Organization
Kagome Co., Ltd.
Division name
Nature & Wellness Research Department
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan
TEL
0287-36-2935
Homepage URL
Shigenori_Suzuki@kagome.co.jp
Sponsor or person
Institute
Kagome Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagome Ethics Committee
Address
F tower, Hamacho, Nihonbashi, Tyuo -ku, Tokyo, Japan
Tel
03-5623-8501
Takuji_Hayakawa@kagome.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
カゴメ株式会社（栃木県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
14
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 20 | Day |
Last modified on
| 2021 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049160
